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Compliance and Quality Specialist – IQVIA

IQVIA
Kuala Lumpur
Salary: Undisclosed

Role Summary

The Compliance and Quality Specialist is responsible for ensuring a comprehensive quality and compliance approach for clinical trials. This role collaborates with both local and global quality functions to monitor compliance risks and support audits and inspections.

Job Description

In this role, you will engage in day-to-day activities that involve monitoring compliance and performing quality control checks within clinical trials. You will also manage local procedures and provide expertise on regulatory intelligence and standard operating procedures.

Key Responsibilities:

  • Monitor compliance risk and perform quality control checks.
  • Support audits and inspections to ensure adherence to regulations.
  • Manage local procedures and documentation related to clinical trials.
  • Provide expertise and guidance on SOP, GCP questions, and regulatory intelligence.
  • Collaborate with local and global quality functions to enhance compliance strategies.
  • Facilitate Root Cause Analysis and development of CAPA.
  • Lead projects to drive compliance productivity and process improvements.

Job Requirements

BA/BS degree in a health or science related field.

3 years of previous Pharmaceutical Industry experience.

2 years of experience within clinical research and development and/or quality assurance.

Excellent working knowledge of FDA/ICH and country-specific regulations.

Demonstrated project leadership skills.

Strong conflict resolution and negotiation skills.

Quick Info

Company

IQVIA

Location

Kuala Lumpur

Salary

Undisclosed

Skills Required

6 skills

Click to submit your application

Required Skills

1

Quality Assurance

2

Regulatory Compliance

3

Project Leadership

4

Problem Solving

5

Strategic Thinking

6

Collaboration

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